BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2890369 · Received December 29, 2012

    Report

    Report Number
    2955842-2012-01482
    Event Type
    Death
    Date Received
    December 29, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AN INSPECTION OF THE SITE'S SYSTEM WAS PERFORMED BY AN INTUITIVE SURGICAL FIELD SERVICE ENGINEER(FSE). INSPECTION OF THE SITE'S DA VINCI SI SURGICAL SYSTEM BY THE FSE FOUND NO ISSUES AND THAT THE SITE'S SYSTEM FUNCTIONED WITHIN SPECIFICATION. THE SITE HAS INDICATED TO THE INTUITIVE SURGICAL CLINICAL SALES REPRESENTATIVE THAT THE SITE IS CURRENTLY PERFORMING AN INTERNAL INVESTIGATION INTO THE REPORTED INCIDENT AND IS UNABLE TO PROVIDE ANY OTHER DETAILS CONCERNING THE INCIDENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO VERIFY ADDITIONAL DETAILS CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED 2 DAYS POST A SUCCESSFUL DA VINCI SI MYOMECTOMY PROCEDURE, THE PATIENT EXPIRED. THE INTUITIVE SURGICAL CLINICAL SALES REPRESENTATIVE (CSR) THAT REPORTED THIS INCIDENT INDICATED THAT ON (B)(6) 2012, THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE REPORTED TO HIM THAT A TENACULUM FORCEPS INSTRUMENT BEING USED DURING THE SURGICAL PROCEDURE WAS NOT MOVING AS IT SHOULD. THE CSR INDICATED THAT HE INSTRUCTED THE SURGEON TO HAVE THE INSTRUMENT REMOVED, CLEANED AND RE-INSTALLED. THE CSR INDICATED THAT THE SITE PROCEEDED USING THE INSTRUMENT AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED TO HAVE OCCURRED AT THE TIME OF THE SURGICAL PROCEDURE. ON (B)(6) 2012, THE INTUITIVE SURGICAL CSR WAS NOTIFIED BY THE SURGEON THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 DUE TO A PERFORATED BOWEL AND THE PATIENT EXPIRED ON (B)(6) 2012. THE CSR INDICATED THAT THE SURGEON INDICATED THE SURGICAL PROCEDURE WENT FINE. THE SURGEON INDICATED TO THE CSR THAT A VIDEO RECORDING OF THE SURGICAL PROCEDURE IS NOT AVAILABLE AND THAT THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN. LATE SUBMISSION OF THE MEDWATCH REPORT IS DUE TO AN REPORTING OVERSIGHT BY THE RESPONSIBLE COMPLAINT HANDLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES